REGULATION (EC) No 1334/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 16 December 2008
on flavourings and certain food ingredients with flavouring properties f or use in and on foods and
amendingCouncilRegulation(EEC)No1601/91,Regulations(EC)No2232/9 6and(EC)No110/2008
and Directive 2000/13/EC
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO-
PEAN UNION,
Having regard to the Treaty establishing the European Commu-
nity, and in particular Article 95 thereof,
Having regard to the proposal from the Commission,Having regard to the Opinion of the European Economic and
Social Committee (
1),
ActinginaccordancewiththeprocedurelaiddowninArticle251
of the Treaty (2),
Whereas:
(1)Council Directive 88/388/EEC of 22 June 1988 on the
approximationofthelawsoftheMemberStatesrelatingtoflavouringsforuseinfoodstuffsandtosourcematerialsfortheir production (
3) needs to be updated in the light of
technical and scientific developments. In the interests ofclarity and efficiency Directive 88/388/EEC should bereplaced by this Regulation.
(2)Council Decision 88/389/EEC of 22 June 1988 on the
establishment, by the Commission, of an inventory of thesourcematerialsandsubstancesusedinthepreparationofflavourings(
4)providesfortheestablishmentofthatinven-
tory within 24 months of its adoption. That Decision isnow obsolete and should be repealed.
(3)Commission Directive 91/71/EEC of 16 January 1991
completingCouncilDirective88/388/EEContheapproxi-mation of the laws of the Member States relating to fla-vourings for use in foodstuffs and to source materials fortheirproduction (
5)laysdownrulesonthelabellingoffla-
vourings. Those rules are replaced by this Regulation andthe Directive should now be repealed.(4)The free movement of safe and wholesome food is an
essentialaspectoftheinternalmarketandcontributessig-nificantly to the health and well-being of citizens, and totheir social and economic interests.
(5)In order to protect human health, this Regulation should
cover flavourings, source materials for flavourings andfoods containing flavourings. It should also cover certainfood ingredients with flavouring properties which areadded to food for the main purpose of adding flavour andwhich contribute significantly to the presence in food ofcertainnaturallyoccurringundesirablesubstances(herein-after referred to as food ingredients with flavouring prop-erties), their source material and foods containing them.
(6)Raw foodstuffs which have not undergone any processing
treatment and non-compound foodstuffs such as spices,herbs,teasandinfusions(e.g.fruitorherbaltea)aswellasmixtures of spices and/or herbs, mixtures of tea and mix-tures for infusion, as long as they are consumed as suchand/or not added to the food, do not fall within the scopeof this Regulation.
(7)Flavourings are used to improve or modify the odour
and/or taste of foods for the benefit of the consumer. Fla-vourings and food ingredients with flavouring propertiesshould only be used if they fulfil the criteria laid down inthis Regulation. They must be safe when used, and certainflavourings should, therefore, undergo a risk assessmentbefore they can be permitted in food. Where possible,attention should be focused on whether or not the use ofcertain flavourings could have any negative consequencesonvulnerablegroups.Theuseofflavouringsmustnotmis-lead the consumer and their presence in food should,therefore,alwaysbeindicatedbyappropriatelabelling.Fla-vourings should, in particular, not be used in a way as tomislead the consumer about issues related to, amongstother things, the nature, freshness, quality of ingredientsused, the naturalness of a product or of the productionprocess, or the nutritional quality of the product. Theapprovalofflavouringsshouldalsotakeintoaccountother
factors relevant to the matter under consideration includ-ing societal, economic, traditional, ethical and environ-mental factors, the precautionary principle and thefeasibility of controls.
(1) OJ C 168, 20.7.2007, p. 34.
(2) Opinion of the European Parliament of 10 July 2007 (OJ C 175 E,
10.7.2008, p. 176), Council Common Position of 10 March 2008(OJC111E,6.5.2008,p.46).PositionoftheEuropeanParliamentof8 July 2008 (not yet published) and Council Decision of 18 Novem-ber 2008.
(
3) OJ L 184, 15.7.1988, p. 61.
(4) OJ L 184, 15.7.1988, p. 67.
(5) OJ L 42, 15.2.1991, p. 25.L 354/34 EN Official Journal of the European Union 31.12.2008(8)Since 1999, the Scientific Committee on Food and subse-
quently the European Food Safety Authority (hereinafterreferredtoastheAuthority)establishedbyRegulation(EC)No178/2002oftheEuropeanParliamentandoftheCoun-cil of 28 January 2002 laying down the general principlesand requirements of food law, establishing the EuropeanFoodSafetyAuthorityandlayingdownproceduresinmat-ters of food safety (
1) have expressed opinions on a num-
ber of substances occurring naturally in source materialsforflavouringsandfoodingredientswithflavouringprop-erties which, according to the Committee of Experts onFlavouringSubstancesoftheCouncilofEurope,raisetoxi-cological concern. Substances for which the toxicologicalconcern was confirmed by the Scientific Committee onFood should be regarded as undesirable substances whichshould not be added as such to food.
(9)Duetotheirnaturaloccurrenceinplants,undesirablesub-
stances might be present in flavouring preparations andfoodingredientswithflavouringproperties.Theplantsareusedtraditionallyasfoodorfoodingredients.Appropriatemaximum levels should be established for the presence ofthese undesirable substances in foods which contribute
most to the human intake of these substances, taking intoaccount both the need to protect human health and theirunavoidable presence in traditional foods.
(10)Maximumlevelsforcertainnaturallyoccurringundesirable
substances should focus on the food or food categorieswhichcontributemosttodietaryintake.Shouldadditionalnaturally occurring undesirable substances pose a risk tothehealthoftheconsumer,maximumlevelsshouldbesetfollowing the opinion of the Authority. Member Statesshould organise controls on a risk basis in line with Regu-lation (EC) No 882/2004 of the European Parliament andof the Council of 29 April 2004 on official controls per-formed to ensure the verification of compliance with feedand food law, animal health and animal welfare rules (
2).
Food producers are obliged to take into account the pres-enceofthesesubstanceswhenusingfoodingredientswithflavouringpropertiesand/orflavouringsforpreparationofallfoodtoensurethatfoodwhichisnotsafeisnotplacedon the market.
(11)Provisions should be established at Community level in
order to prohibit, or restrict the use of, certain plant, ani-mal,microbiologicalormineralmaterialswhichraisecon-cern for human health in the production of flavouringsand food ingredients with flavouring properties and theirapplications in food production.(12)Risk assessments should be carried out by the Authority.
(13)In order to ensure harmonisation, the risk assessment and
approval of flavourings and source materials that need toundergoanevaluationshouldbecarriedoutinaccordancewith the procedure laid down in Regulation (EC)No 1331/2008 of the European Parliament and of theCouncil of 16 December 2008 establishing a commonauthorisation procedure for food additives, food enzymesand food flavourings (
3).
(14)Flavouring substances are defined chemical substances,
whichincludeflavouringsubstancesobtainedbychemicalsynthesisorisolatedusingchemicalprocesses,andnaturalflavouring substances. An evaluation programme of fla-vouring substances is ongoing in accordance with Regula-tion (EC) No 2232/96 of the European Parliament and ofthe Council of 28 October 1996 laying down a Commu-nity procedure for flavouring substances used or intendedfor use in or on foodstuffs (
4). Under that Regulation a list
of flavouring substances is to be adopted within five yearsofadoptionofthatprogramme.Anewdeadlineshouldbeset for the adoption of that list. That list will be proposed
for inclusion in the list referred to in Article 2(1) of Regu-lation (EC) No 1331/2008.
(15)Flavouringpreparationsareflavouringsotherthandefined
chemical substances obtained from materials of vegetable,animal or microbiological origin, by appropriate physical,enzymatic or microbiological processes, either in the rawstate of the material or after processing for human con-sumption.Flavouringpreparationsproducedfromfooddonot need to undergo an evaluation or an approval proce-dure for use in and on foods unless there is doubt abouttheirsafety.However,thesafetyofflavouringpreparationsproducedfromnon-foodmaterialshouldbeevaluatedandapproved.
(16)Regulation (EC) No 178/2002 defines food as any sub-
stance or product, whether processed, partially processedor unprocessed, intended to be, or reasonably expected tobe, ingested by humans. Materials of vegetable, animal ormicrobiological origin, for which it can be sufficientlydemonstrated that they have hitherto been used for theproductionofflavourings,areconsideredtobefoodmate-rials for this purpose, even though some of these sourcematerials, such as rose wood and strawberry leaves, maynot have been used for food as such. They do not need tobe evaluated.
(1) OJ L 31, 1.2.2002, p. 1.
(2) OJL165,30.4.2004,p.1.CorrectedversioninOJL191,28.5.2004,
p. 1.(3) See page 1 of this Official Journal.
(4) OJ L 299, 23.11.1996, p. 1.31.12.2008 EN Official Journal of the European Union L 354/35(17)Likewise,thermalprocessflavouringsproducedfromfood
underspecifiedconditionsneednotundergoanevaluationor an approval procedure for use in and on foods unlessthere is doubt about their safety. However, the safety ofthermal process flavourings produced from non-foodmaterial or not complying with certain conditions of pro-duction should be evaluated and approved.
(18)Regulation (EC) No 2065/2003 of the European Parlia-
mentandoftheCouncilof10November2003onsmokeflavouringsusedorintendedforuseinoronfoods (
1)lays
down a procedure for the safety assessment and approvalofsmokeflavouringsandaimstoestablishalistofprimarysmoke condensates and primary tar fractions the use ofwhich is authorised to the exclusion of all others.
(19)Flavour precursors such as carbohydrates, oligo-peptides
and amino acids impart flavour to food by chemical reac-tionswhichoccurduringfoodprocessing.Flavourprecur-sors produced from food do not need to undergo anevaluation or an approval procedure for use in and onfoodsunlessthereisdoubtabouttheirsafety.However,thesafetyofflavourprecursorsproducedfromnon-foodmate-rial should be evaluated and approved.
(20)Other flavourings which do not fall under the definitions
of the previously mentioned flavourings may be used inandonfoodsaftertheyhaveundergoneanevaluationandapproval procedure. An example could be flavouringswhich are obtained by heating oil or fat to an extremelyhightemperatureforaveryshortperiodoftime,resultingin a grill-like flavour.
(21)Material of vegetable, animal, microbiological or mineral
originotherthanfoodmayonlybeauthorisedforthepro-duction of flavourings after its safety has been evaluatedscientifically. It might be necessary to authorise the use ofonly certain parts of the material or to set conditions ofuse.
(22)Flavourings can contain food additives as permitted by
Regulation (EC) No 1333/2008 of the European Parlia-ment and of the Council of 16 December 2008 on foodadditives (
2) and/or other food ingredients for technologi-
calpurposessuchasfortheirstorage,standardisation,dilu-tion or dissolution and stabilisation.
(23)A flavouring or a source material which falls within the
scope of Regulation (EC) No 1829/2003 of the EuropeanParliament and of the Council of 22 September 2003on genetically modified food and feed (
3) should beauthorised in accordance with that Regulation as well as
under this Regulation.
(24)Flavourings remain subject to the general labelling obliga-
tions provided for in Directive 2000/13/EC of the Euro-pean Parliament and of the Council of 20 March 2000 onthe approximation of the laws of the Member States relat-ing to the labelling, presentation and advertising of food-stuffs (
4) and, as the case may be, in Regulations (EC)
No1829/2003andRegulation(EC)No1830/2003oftheEuropean Parliament and of the Council of 22 September2003 concerning the traceability and labelling of geneti-cally modified organisms and the traceability of food andfeed products produced from genetically modified organ-isms (
5).Inaddition,specificprovisionsonthelabellingof
flavouringssoldassuchtothemanufacturerortothefinalconsumer should be contained in this Regulation.
(25)Flavouring substances or flavouring preparations should
onlybelabelledas‘natural’iftheycomplywithcertaincri-teria which ensure that consumers are not misled.
(26)Specificinformationrequirementsshouldensurethatcon-
sumersarenotmisledconcerningthesourcematerialusedfor the production of natural flavourings. In particular, ifthe term natural is used to describe a flavour, the flavour-ing components used should be entirely of natural origin.In addition, the source of the flavourings should belabelled, except when the source materials referred towouldnotberecognisedintheflavourortasteofthefood.If a source is mentioned, at least 95 % of the flavouringcomponent should be obtained from the material referredto. As the use of flavourings should not mislead the con-sumer,theothermaximum5 %canonlybeusedforstan-dardisationortogivea,forexample,morefresh,pungent,ripe or green note to the flavouring. When less than 95 %of the flavouring component derived from the sourcereferredtohasbeenusedandtheflavourofthesourcecanstill be recognised, the source should be revealed togetherwith a statement that other natural flavourings have beenadded, for example cacao extract in which other naturalflavourings have been added to impart a banana note.
(27)Consumersshouldbeinformedifthesmokytasteofapar-
ticularfoodisduetotheadditionofsmokeflavourings.Inaccordance with Directive 2000/13/EC, the labellingshould not confuse the consumer as to whether the prod-uct is smoked conventionally with fresh smoke or treatedwithsmokeflavourings.Directive2000/13/ECneedstobeadapted to the definitions of flavourings, smoke flavour-ings and the term ‘natural’ for the description of flavour-ings laid down in this Regulation.
(1) OJ L 309, 26.11.2003, p. 1.
(2) See page 16 of this Official Journal.
(3) OJ L 268, 18.10.2003, p. 1.(4) OJ L 109, 6.5.2000, p. 29.
(5) OJ L 268, 18.10.2003, p. 24.L 354/36 EN Official Journal of the European Union 31.12.2008(28)Fortheevaluationofthesafetyofflavouringsubstancesfor
humanhealth,informationontheconsumptionanduseofflavouring substances is crucial. The amounts of flavour-ing substances added to food should therefore be checkedon a regular basis.
(29)The measures necessary for the implementation of this
Regulation should be adopted in accordance with CouncilDecision 1999/468/EC of 28 June 1999 laying down theprocedures for the exercise of implementing powers con-ferred on the Commission (
1).
(30)In particular the Commission should be empowered to
amendtheAnnexestothisRegulationandtoadoptappro-priatetransitionalmeasuresregardingtheestablishmentofthe Community list. Since those measures are of generalscopeandaredesignedtoamendnon-essentialelementsofthis Regulation, inter alia, by supplementing it with new
non-essential elements, they must be adopted in accor-dance with the regulatory procedure with scrutiny pro-vided for in Article 5a of Decision 1999/468/EC.
(31)When,onimperativegroundsofurgency,thenormaltime-
limitsfortheregulatoryprocedurewithscrutinycannotbecomplied with, the Commission should be able to applythe urgency procedure provided for in Article 5a(6) ofDecision 1999/468/EC for the adoption of measuresdescribed in Article 8(2) and amendments to Annexes IIto V to this Regulation.
(32)Annexes II to V to this Regulation should be adapted as
necessary to scientific and technical progress, taking intoaccount the information provided by producers and usersof flavourings and/or resulting from the monitoring andcontrols by the Member States.
(33)In order to develop and update Community law on fla-
vourings in a proportionate and effective way, it is neces-sarytocollectdata,shareinformationandcoordinateworkbetweenMemberStates.Forthatpurpose,itmaybeusefulto undertake studies to address specific issues with a viewto facilitating the decision-making process. It is appropri-ate that the Community finance such studies as part of itsbudgetary procedure. The financing of such measures iscovered by Regulation (EC) No 882/2004.
(34)Pending the establishment of the Community list, provi-
sionshouldbemadefortheevaluationandapprovaloffla-vouring substances which are not covered by theevaluation programme provided for in Regulation (EC)No2232/96.Atransitionalregimeshouldthereforebelaid
down. Under that regime such flavouring substancesshould be evaluated and approved in accordance with theprocedure laid down in Regulation (EC) No 1331/2008.However,thetimeperiodsprovidedforinthatRegulationfortheadoptionbytheAuthorityofitsopinionandforthesubmission by the Commission to the Standing Commit-
tee on the Food Chain and Animal Health of a draft regu-lation updating the Community list should not apply,becausepriorityshouldbegiventotheongoingevaluationprogramme.
(35)SincetheobjectiveofthisRegulation,namelytolaydown
Community rules on the use of flavourings and certainfood ingredients with flavouring properties in and onfoods, cannot be sufficiently achieved by the MemberStates and can therefore, in the interests of market unityandahighlevelofconsumerprotection,bebetterachievedatCommunitylevel,theCommunitymayadoptmeasures,inaccordancewiththeprincipleofsubsidiaryassetoutinArticle5oftheTreaty.Inaccordancewiththeprincipleofproportionality, as set out in that Article, this Regulationdoes not go beyond what is necessary in order to achievethat objective.
(36)Council Regulation (EEC) No 1601/91 of 10 June 1991
laying down general rules on the definition, descriptionand presentation of aromatised wines, aromatised wine-baseddrinksandaromatisedwine-productcocktails(
2)and
Regulation(EC)No110/2008oftheEuropeanParliamentand of the Council of 15 January 2008 on the definition,description, presentation, labelling and the protection ofgeographical indications of spirit drinks (
3) need to be
adapted to certain new definitions laid down in thisRegulation.
(37)Regulations(EEC)No1601/91,(EC)No2232/96and(EC)
No 110/2008 and Directive 2000/13/EC should beamended accordingly,
HAVE ADOPTED THIS REGULATION:
CHAPTER I
SUBJECT MATTER, SCOPE AND DEFINITIONS
Article 1
Subject matter
ThisRegulationlaysdownrulesonflavouringsandfoodingredi-
ents with flavouring properties for use in and on foods with aview to ensuring the effective functioning of the internal marketwhilst ensuring a high level of protection of human health and ahigh level of consumer protection, including the protection ofconsumer interests and fair practices in food trade, taking intoaccount, where appropriate, the protection of the environment.
(1) OJ L 184, 17.7.1999, p. 23.(2) OJ L 149, 14.6.1991, p. 1.
(3) OJ L 39, 13.2.2008, p. 16.31.12.2008 EN Official Journal of the European Union L 354/37For those purposes, this Regulation provides for:
(a) a Community list of flavourings and source materials
approved for use in and on foods, set out in Annex I (here-inafter referred to as the ‘Community list’);
(b) conditions of use of flavourings and food ingredients with
flavouring properties in and on foods;
(c) rules on the labelling of flavourings.
Article 2
Scope
1. This Regulation shall apply to:(a) flavourings which are used or intended to be used in or on
foods, without prejudice to more specific provisions laiddown in Regulation (EC) No 2065/2003;
(b) food ingredients with flavouring properties;(c) foodcontainingflavouringsand/orfoodingredientswithfla-
vouring properties;
(d) source materials for flavourings and/or source materials for
food ingredients with flavouring properties.
2. This Regulation shall not apply to:(a) substanceswhichhaveexclusivelyasweet,sourorsaltytaste;(b) raw foods;(c) non-compound foods and mixtures such as, but not exclu-
sively,fresh,driedorfrozenspicesand/orherbs,mixturesofteaandmixturesforinfusionassuchaslongastheyhavenotbeen used as food ingredients.
Article 3
Definitions
1. For the purposes of this Regulation, the definitions laid
downinRegulations(EC)No178/2002and(EC)No1829/2003shall apply.
2. For the purposes of this Regulation, the following defini-
tions shall also apply:
(a) ‘flavourings’ shall mean products:
(i) not intended to be consumed as such, which are added
tofoodinordertoimpartormodifyodourand/ortaste;(ii) made or consisting of the following categories: flavour-
ingsubstances,flavouringpreparations,thermalprocessflavourings, smoke flavourings, flavour precursors orother flavourings or mixtures thereof;
(b) ‘flavouring substance’ shall mean a defined chemical sub-
stance with flavouring properties;
(c) ‘natural flavouring substance’ shall mean a flavouring sub-
stanceobtainedbyappropriatephysical,enzymaticormicro-biological processes from material of vegetable, animal ormicrobiologicalorigineitherintherawstateorafterprocess-ing for human consumption by one or more of the tradi-tional food preparation processes listed in Annex II. Naturalflavouringsubstancescorrespondtosubstancesthatarenatu-rally present and have been identified in nature;
(d) ‘flavouring preparation’ shall mean a product, other than a
flavouring substance, obtained from:
(i) food by appropriate physical, enzymatic or microbio-
logicalprocesseseitherintherawstateofthematerialorafter processing for human consumption by one ormoreofthetraditionalfoodpreparationprocesseslistedin Annex II;
and/or
(ii) material of vegetable, animal or microbiological origin,
other than food, by appropriate physical, enzymatic ormicrobiological processes, the material being taken assuchorpreparedbyoneormoreofthetraditionalfoodpreparation processes listed in Annex II;
(e) ‘thermal process flavouring’ shall mean a product obtained
after heat treatment from a mixture of ingredients not nec-essarilyhavingflavouringpropertiesthemselves,ofwhichatleast one contains nitrogen (amino) and another is a reduc-
ingsugar;theingredientsfortheproductionofthermalpro-cess flavourings may be:
(i) food;
and/or
(ii) source material other than food;
(f) ‘smokeflavouring’shallmeanaproductobtainedbyfraction-
ation and purification of a condensed smoke yielding pri-mary smoke condensates, primary tar fractions and/orderivedsmokeflavouringsasdefinedinpoints(1),(2)and(4)of Article 3 of Regulation (EC) No 2065/2003;L 354/38
EN Official Journal of the European Union 31.12.2008(g) ‘flavourprecursor’shallmeanaproduct,notnecessarilyhav-
ing flavouring properties itself, intentionally added to foodfor the sole purpose of producing flavour by breaking downor reacting with other components during food processing;it may be obtained from:
(i) food;
and/or
(ii) source material other than food;
(h) ‘other flavouring’ shall mean a flavouring added or intended
tobeaddedtofoodinordertoimpartodourand/ortasteandwhich does not fall under definitions (b) to (g);
(i) ‘foodingredientwithflavouringproperties’shallmeanafood
ingredient other than flavourings which may be added tofoodforthemainpurposeofaddingflavourtoitormodify-ingitsflavourandwhichcontributessignificantlytothepres-ence in food of certain naturally occurring undesirablesubstances;
(j) ‘source material’ shall mean material of vegetable, animal,
microbiologicalormineraloriginfromwhichflavouringsorfood ingredients with flavouring properties are produced; itmay be:
(i) food;
or
(ii) source material other than food;
(k) ‘appropriate physical process’ shall mean a physical process
which does not intentionally modify the chemical nature ofthe components of the flavouring, without prejudice to thelisting of traditional food preparation processes in Annex II,and does not involve, inter alia, the use of singlet oxygen,
ozone, inorganic catalysts, metal catalysts, organometallicreagents and/or UV radiation.
3. For the purpose of the definitions listed in paragraph 2(d),
(e), (g) and (j), source materials for which hitherto there is signifi-cant evidence of use for the production of flavourings shall beconsidered as food for the purpose of this Regulation.
4. Flavourings may contain food additives as permitted by
Regulation (EC) No 1333/2008 and/or other food ingredientsincorporated for technological purposes.CHAPTER II
CONDITIONS FOR USE OF FLAVOURINGS, FOOD
INGREDIENTS WITH FLAVOURING PROPERTIES AND
SOURCE MATERIALS
Article 4
General conditions for use of flavourings or food
ingredients with flavouring properties
Only flavourings or food ingredients with flavouring properties
whichmeetthefollowingconditionsmaybeusedinoronfoods:
(a) they do not, on the basis of the scientific evidence available,
pose a safety risk to the health of the consumer; and
(b) their use does not mislead the consumer.
Article 5
Prohibition of non-compliant flavourings and/or
non-compliant food
No person shall place on the market a flavouring or any food in
which such a flavouring and/or food ingredients with flavouringproperties are present if their use does not comply with thisRegulation.
Article 6
Presence of certain substances
1. Substances listed in Part A of Annex III shall not be added
as such to food.
2. Without prejudice to Regulation (EC) No 110/2008, maxi-
mumlevelsofcertainsubstances,naturallypresentinflavouringsand/or food ingredients with flavouring properties, in the com-poundfoodslistedinPartBofAnnexIIIshallnotbeexceededasaresultoftheuseofflavouringsand/orfoodingredientswithfla-vouringpropertiesinandonthosefoods.Themaximumlevelsofthe substances set out in Annex III shall apply to foods as mar-keted, unless otherwise stated. By way of derogation from thisprinciple, for dried and/or concentrated foods which need to bereconstituted, the maximum levels shall apply to the food asreconstituted according to the instructions on the label, takinginto account the minimum dilution factor.
3. Detailed rules for the implementation of paragraph 2 may
be adopted in accordance with the regulatory procedure referredto in Article 21(2), following the opinion of the European FoodSafetyAuthority(hereinafterreferredtoasthe‘Authority’),wherenecessary.31.12.2008
EN Official Journal of the European Union L 354/39Article 7
Use of certain source materials
1. Source materials listed in Part A of Annex IV shall not be
used for the production of flavourings and/or food ingredientswith flavouring properties.
2. Flavourings and/or food ingredients with flavouring prop-
ertiesproducedfromsourcematerialslistedinPartBofAnnexIVmay be used only under the conditions indicated in that Annex.
Article 8
Flavourings and food ingredients with flavouring
properties for which evaluation and approval are not
required
1. The following flavourings and food ingredients with fla-
vouring properties may be used in or on foods without an evalu-ation and approval under this Regulation, provided that theycomply with Article 4:
(a) flavouring preparations referred to in Article 3(2)(d)(i);
(b) thermal process flavourings referred to in Article 3(2)(e)(i)
whichcomplywiththeconditionsfortheproductionofther-malprocessflavouringsandmaximumlevelsforcertainsub-stances in thermal process flavourings set out in Annex V;
(c) flavour precursors referred to in Article 3(2)(g)(i);(d) food ingredients with flavouring properties.2. Notwithstanding paragraph 1, if the Commission, a Mem-
berStateortheAuthorityexpressesdoubtsconcerningthesafetyof a flavouring or food ingredient with flavouring propertiesreferredtoinparagraph1,ariskassessmentofsuchflavouringorfoodingredientwithflavouringpropertiesshallbecarriedoutbythe Authority. Articles 4, 5 and 6 of Regulation (EC)No1331/2008shallthenapply mutatismutandis .Ifnecessary,the
Commission shall adopt measures, following the opinion of theAuthority,whicharedesignedtoamendnon-essentialelementsofthisRegulation, interalia,bysupplementingit,inaccordancewith
theregulatoryprocedurewithscrutinyreferredtoinArticle21(3).Such measures shall be laid down in Annexes III, IV and/or Vwhere appropriate. On imperative grounds of urgency, theCommission may use the urgency procedure referred to inArticle 21(4).CHAPTER III
COMMUNITY LIST OF FLAVOURINGS AND SOURCE
MATERIALS APPROVED FOR USE IN OR ON FOODS
Article 9
Flavourings and source materials for which an evaluation
and approval is required
This Chapter shall apply to:(a) flavouring substances;(b) flavouring preparations referred to in Article 3(2)(d)(ii);(c) thermal process flavourings obtained by heating ingredients
which fall partially or totally within Article 3(2)(e)(ii) and/or
for which the conditions for the production of thermal pro-cessflavouringsand/orthemaximumlevelsforcertainunde-sirable substances set out in Annex V are not met;
(d) flavour precursors referred to in Article 3(2)(g)(ii);(e) other flavourings referred to in Article 3(2)(h);(f) source materials other than food referred to in
Article 3(2)(j)(ii).
Article 10
Community list of flavourings and source materials
Of the flavourings and source materials referred to in Article 9,
only those included in the Community list may be placed on themarket as such and used in or on foods under the conditions ofuse specified therein, where applicable.
Article 11
Inclusion of flavourings and source materials in the
Community list
1. A flavouring or source material may be included in the
Community list, in accordance with the procedure laid down byRegulation (EC) No 1331/2008, only if it complies with the con-ditions set out in Article 4 of this Regulation.
2. The entry for a flavouring or source material in the Com-
munity list shall specify:
(a) the identification of the flavouring or the source material
approved;
(b) where necessary, the conditions under which the flavouring
may be used.L 354/40
EN Official Journal of the European Union 31.12.20083. The Community list shall be amended in accordance with
the procedure referred to in Regulation (EC) No 1331/2008.
Article 12
Flavourings or source materials falling within the scope of
Regulation (EC) No 1829/2003
1. A flavouring or source material falling within the scope of
Regulation (EC) No 1829/2003 may be included in the Commu-nitylistinAnnexIinaccordancewiththisRegulationonlywhenit is covered by an authorisation in accordance with Regulation(EC) No 1829/2003.
2. When a flavouring already included in the Community list
is produced from a different source falling within the scope ofRegulation (EC) No 1829/2003, it will not require a new autho-risation under this Regulation, as long as the new source is cov-ered by an authorisation in accordance with Regulation (EC)No 1829/2003 and the flavouring complies with the specifica-tions established under this Regulation.
Article 13
Interpretation decisions
Where necessary, it may be decided in accordance with the regu-
latory procedure referred to in Article 21(2):
(a) whether or not a given substance or mixture of substances,
material or type of food falls within the categories listed inArticle 2(1);
(b) to which specific category, defined in Article 3(2)(b) to (j), a
given substance belongs;
(c) whether or not a particular product belongs to a food cat-
egoryorisafoodreferredtoinAnnexIorAnnexIII,PartB.
CHAPTER IV
LABELLING
Article 14
Labelling of flavourings not intended for sale to the final
consumer
1. Flavouringsnotintendedforsaletothefinalconsumermay
only be marketed with the labelling provided for in Articles 15and16,whichmustbeeasilyvisible,clearlylegibleandindelible.TheinformationprovidedforinArticle15shallbeinalanguageeasily understandable to purchasers.
2. Within its own territory, the Member State in which the
productismarketedmay,inaccordancewiththeTreaty,stipulatethat the information provided for in Article 15 shall be given inone or more of the official languages of the Community, to bedetermined by that Member State. This shall not preclude suchinformation from being indicated in several languages.Article 15
General labelling requirements for flavourings not
intended for sale to the final consumer
1. Where flavourings not intended for sale to the final con-
sumeraresoldsinglyormixedwitheachotherand/orwithotherfood ingredients and/or with other substances added to them inaccordance with Article 3(4), their packaging or containers shallbear the following information:
(a) the sales description: either the word ‘flavouring’ or a more
specific name or description of the flavouring;
(b) thestatementeither‘forfood’orthestatement‘restricteduse
infood’oramorespecificreferencetoitsintendedfooduse;
(c) if necessary, the special conditions for storage and/or use;(d) a mark identifying the batch or lot;(e) in descending order of weight, a list of:
(i) the categories of flavourings present and(ii) the names of each of the other substances or materials
in the product or, where appropriate, their E-number;
(f) thenameorbusinessnameandaddressofthemanufacturer,
packager or seller;
(g) an indication of the maximum quantity of each component
orgroupofcomponentssubjecttoquantitativelimitationinfood and/or appropriate information in clear and easilyunderstandabletermsenablingthepurchasertocomplywiththis Regulation or other relevant Community law;
(h) the net quantity;(i) a date of minimum durability or use-by-date;(j) where relevant, information on a flavouring or other sub-
stances referred to in this Article and listed in Annex IIIa toDirective 2000/13/EC as regards the indication of the ingre-dients present in foodstuffs.
2. By way of derogation from paragraph 1, the information
requiredinpoints(e)and(g)ofthatparagraphmayappearmerelyon the documents relating to the consignment which are to besupplied with or prior to the delivery, provided that the indica-tion ‘not for retail sale’ appears on an easily visible part of thepackaging or container of the product in question.
3. By way of derogation from paragraph 1, where flavourings
aresuppliedintankers,alloftheinformationmayappearmerelyon the accompanying documents relating to the consignmentwhich are to be supplied with the delivery.31.12.2008
EN Official Journal of the European Union L 354/41Article 16
Specific requirements for use of the term ‘natural’
1. If the term ‘natural’ is used to describe a flavouring in the
sales description referred to in Article 15(1)(a) the provisions ofparagraphs 2 to 6 of this Article shall apply.
2. The term ‘natural’ for the description of a flavouring may
onlybeusediftheflavouringcomponentcomprisesonlyflavour-ing preparations and/or natural flavouring substances.
3. Theterm‘naturalflavouringsubstance(s)’mayonlybeused
for flavourings in which the flavouring component containsexclusively natural flavouring substances.
4. The term ‘natural’ may only be used in combination with a
reference to a food, food category or a vegetable or animal fla-vouring source if the flavouring component has been obtainedexclusively or by at least 95 % by w/w from the source materialreferred to.
The description shall read ‘natural “food(s) or food category or
source(s)” flavouring’.
5. Theterm‘natural“food(s)orfoodcategoryorsource(s)”fla-
vouring with other natural flavourings’ may only be used if theflavouring component is partially derived from the source mate-rial referred to, the flavour of which can easily be recognised.
6. The term ‘natural flavouring’ may only be used if the fla-
vouringcomponentisderivedfromdifferentsourcematerialsandwhere a reference to the source materials would not reflect theirflavour or taste.
Article 17
Labelling of flavourings intended for sale to the final
consumer
1. WithoutprejudicetoDirective2000/13/EC,CouncilDirec-
tive 89/396/EEC of 14 June 1989 on indications or marks iden-tifyingthelottowhichafoodstuffbelongs(
1)andRegulation(EC)
No 1829/2003, flavourings sold singly or mixed with each otherand/or with other food ingredients and/or to which other sub-stancesareaddedandwhichareintendedforsaletothefinalcon-sumer may be marketed only if their packaging contains thestatementeither‘forfood’or‘restricteduseinfood’oramorespe-cific reference to their intended food use, which must be easilyvisible, clearly legible and indelible.
2. If the term ‘natural’ is used to describe a flavouring in the
sales description referred to in Article 15(1)(a), Article 16 shallapply.Article 18
Other labelling requirements
Articles 14 to 17 shall be without prejudice to more detailed or
more extensive laws, regulations or administrative provisionsregarding weights and measures or applying to the presentation,classification, packaging and labelling of dangerous substancesand preparations or applying to the transport of such substancesand preparations.
CHAPTER V
PROCEDURAL PROVISIONS AND IMPLEMENTATION
Article 19
Reporting by the food business operators
1. A producer or user of a flavouring substance, or the repre-
sentative of such producer or user, shall, at the request of theCommission, inform it of the amount of the substance added tofoods in the Community in a period of 12 months. The informa-tionprovidedinthiscontextshallbetreatedasconfidentialinso-far as this information is not required for the safety assessment.
Information on the use levels for specific food categories in the
Community shall be made available to Member States by theCommission.
2. Where applicable, for a flavouring already approved under
this Regulation which is prepared by production methods orstartingmaterialssignificantlydifferentfromthoseincludedintherisk assessment of the Authority, a producer or user shall, beforemarketing the flavouring, submit to the Commission the neces-sary data to allow an evaluation of the flavouring to be under-taken by the Authority with regard to the modified productionmethod or characteristics.
3. A producer or user of flavourings and/or source materials
shallinformtheCommissionimmediatelyofanynewscientificortechnical information which is known and accessible to him andwhich might affect the assessment of the safety of the flavouringsubstance.
4. Detailed rules for the implementation of paragraph 1 shall
be adopted in accordance with the regulatory procedure referredto in Article 21(2).
Article 20
Monitoring and reporting by the Member States
1. Member States shall establish systems to monitor the con-
sumption and use of flavourings set out in the Community listand the consumption of the substances listed in Annex III on arisk-based approach, and shall report their findings with appro-priate frequency to the Commission and to the Authority.
(1) OJ L 186, 30.6.1989, p. 21.L 354/42 EN Official Journal of the European Union 31.12.20082. After the Authority has been consulted, a common meth-
odology for the gathering by Member States of information onthe consumption and use of flavourings set out in the Commu-nitylistandofthesubstanceslistedinAnnexIIIshallbeadoptedin accordance with the regulatory procedure referred to inArticle 21(2) by 20 January 2011.
Article 21
Committee
1. TheCommissionshallbeassistedbytheStandingCommit-
tee on the Food Chain and Animal Health.
2. Wherereferenceismadetothisparagraph,Articles5and7
of Decision 1999/468/EC shall apply, having regard to the pro-visions of Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC
shall be set at three months.
3. Where reference is made to this paragraph, Article 5a(1)
to (4) and Article 7 of Decision 1999/468/EC shall apply, havingregard to the provisions of Article 8 thereof.
4. Wherereferenceismadetothisparagraph,Article5a(1),(2),
(4) and (6) and Article 7 of Decision 1999/468/EC shall apply,having regard to the provisions of Article 8 thereof.
Article 22
Amendments to Annexes II to V
Amendments to Annexes II to V to this Regulation to reflect sci-
entific and technical progress which are designed to amend non-essential elements of this Regulation shall be adopted inaccordance with the regulatory procedure with scrutiny referredtoinArticle21(3),followingtheopinionoftheAuthority,wherenecessary.
On imperative grounds of urgency, the Commission may use the
urgency procedure referred to in Article 21(4).
Article 23
Community financing of harmonised policies
The legal basis for the financing of measures resulting from this
Regulation shall be Article 66(1)(c) of Regulation (EC)No 882/2004.
CHAPTER VI
TRANSITIONAL AND FINAL PROVISIONS
Article 24
Repeals
1. Directive 88/388/EEC, Decision 88/389/EEC and Directive
91/71/EEC shall be repealed from 20 January 2011.2. Regulation(EC)No2232/96shallberepealedfromthedate
of application of the list referred to in Article 2(2) of thatRegulation.
3. References to the repealed acts shall be construed as refer-
ences to this Regulation.
Article 25
Introduction of the list of flavouring substances into the
Community list of flavourings and source materials and
transitional regime
1. The Community list shall be established by introducing the
list of flavouring substances referred to in Article 2(2) of Regula-tion(EC)No2232/96intoAnnexItothisRegulationatthetimeof its adoption.
2. Pending the establishment of the Community list, Regula-
tion (EC) No 1331/2008 shall apply for the evaluation andapproval of flavouring substances which are not covered by theevaluation programme provided for in Article 4 of Regulation(EC) No 2232/96.
By way of derogation from that procedure, the period of nine
monthsreferredtoinArticle5(1)andArticle7ofRegulation(EC)No 1331/2008 shall not apply to such evaluation and approval.
3. Any appropriate transitional measures which are designed
to amend non-essential elements of this Regulation, inter alia,b y
supplementing it, shall be adopted in accordance with the regu-latory procedure with scrutiny referred to in Article 21(3).
Article 26
Amendments to Regulation (EEC) No 1601/91
Article 2(1) is hereby amended as follows:1. in point (a), the first sub-indent of the third indent shall be
replaced by the following:
‘— flavouring substances and/or flavouring preparations as
defined in Article 3(2)(b) and (d) of Regulation (EC)No 1334/2008 of the European Parliament and of theCouncil of 16 December 2008 on flavourings and cer-tain food ingredients with flavouring properties for usein and on foods (
*), and/or
(*) OJ L 354, 31.12.2008, p. 34.’
2. inpoint(b),thefirstsub-indentofthesecondindentshallbe
replaced by the following:
‘— flavouring substances and/or flavouring preparations as
defined in Article 3(2)(b) and (d) of Regulation (EC)No 1334/2008, and/or’;
3. inpoint(c),thefirstsub-indentofthesecondindentshallbe
replaced by the following:
‘— flavouring substances and/or flavouring preparations as
defined in Article 3(2)(b) and (d) of Regulation (EC)No 1334/2008, and/or’.31.12.2008
EN Official Journal of the European Union L 354/43Article 27
Amendment to Regulation (EC) No 2232/96
Article 5(1) of Regulation (EC) No 2232/96 shall be replaced by
the following:
‘1. The list of flavouring substances referred to in Article 2(2)
shallbeadoptedinaccordancewiththeprocedurereferredtoin Article 7 by 31 December 2010 at the latest.’.
Article 28
Amendments to Regulation (EC) No 110/2008
Regulation (EC) No 110/2008 is hereby amended as follows:1. in Article 5(2), point (c) shall be replaced by the following:
‘(c) contain flavouring substances as defined in
Article 3(2)(b) of Regulation (EC) No 1334/2008 of theEuropean Parliament and of the Council of 16 Decem-ber 2008 on flavourings and certain food ingredientswithflavouringpropertiesforuseinandonfoods(
*)and
flavouring preparations as defined in Article 3(2)(d) ofthat Regulation;
(*) OJ L 354, 31.12.2008, p. 34.’
2. in Article 5(3), point (c) shall be replaced by the following:
‘(c) contain one or more flavourings as defined in
Article 3(2)(a) of Regulation (EC) No 1334/2008;’;
3. in Annex I, point (9) shall be replaced by the following:
‘(9)Flavouring
Flavouring means using in the preparation of a spirit
drink one or more of the flavourings defined inArticle 3(2)(a) of Regulation (EC) No 1334/2008.’;
4. Annex II shall be amended as follows:
(a) paragraph 19(c) shall be replaced by the following:
‘(c) Other flavouring substances as defined in
Article 3(2)(b) of Regulation (EC) No 1334/2008and/or flavouring preparations as defined inArticle 3(2)(d) of that Regulation, and/or aromaticplants or parts of aromatic plants may be used inaddition, but the organoleptic characteristics ofjuniper must be discernible, even if they are some-times attenuated.’;
(b) paragraph 20(c) shall be replaced by the following:
‘(c) Only flavouring substances as defined in
Article 3(2)(b) of Regulation (EC) No 1334/2008and/or flavouring preparations as defined inArticle 3(2)(d) of that Regulation shall be used for
the production of gin so that the taste is predomi-nantly that of juniper.’;
(c) paragraph 21(a) (ii) shall be replaced by the following:
‘(ii) the mixture of the product of such distillation and
ethyl alcohol of agricultural origin with the samecomposition,purityandalcoholicstrength;flavour-ing substances and/or flavouring preparations asspecified in category 20(c) may also be used to fla-vour distilled gin.’;
(d) paragraph 23(c) shall be replaced by the following:
‘(c) Other flavouring substances as defined in
Article 3(2)(b) of Regulation (EC) No 1334/2008and/or flavouring preparations as defined inArticle 3(2)(d) of that Regulation may additionallybe used but there must be a predominant taste ofcaraway.’;
(e) paragraph 24(c) shall be replaced by the following:
‘(c) Other natural flavouring substances as defined in
Article 3(2)(c) of Regulation (EC) No 1334/2008and/or flavouring preparations as defined inArticle 3(2)(d) of that Regulation may additionallybe used, but the flavour of these drinks is largely
attributabletodistillatesofcaraway(CarumcarviL.)and/ordill(AnethumgraveolensL.)seeds,theuseofessential oils being prohibited.’;
(f) paragraph 30(a) shall be replaced by the following:
‘(a) Bitter-tasting spirit drinks or bitter are spirit drinks
with a predominantly bitter taste produced by fla-vouringethylalcoholofagriculturaloriginwithfla-vouring substances as defined in Article 3(2)(b) ofRegulation (EC) No 1334/2008 and/or flavouringpreparations as defined in Article 3(2)(d) of thatRegulation.’;
(g) inparagraph32(c),thefirstsubparagraphandtheintro-
ductory part of the second subparagraph shall bereplaced by the following:
‘(c) Flavouring substances as defined in Article 3(2)(b)
of Regulation (EC) No 1334/2008 and flavouringpreparations as defined in Article 3(2)(d) of thatRegulation may be used in the preparation ofliqueur. However, only natural flavouring sub-stances as defined in Article 3(2)(c) of Regulation(EC) No 1334/2008 and flavouring preparations asdefinedinArticle3(2)(d)ofthatRegulationshallbeused in the preparation of the following liqueurs:’;L 354/44
EN Official Journal of the European Union 31.12.2008(h) paragraph 41(c) shall be replaced by the following:
‘(c) Only flavouring substances as defined in
Article 3(2)(b) of Regulation (EC) No 1334/2008and flavouring preparations as defined inArticle3(2)(d)ofthatRegulationmaybeusedinthepreparation of egg liqueur or advocaat or avocat oradvokat.’;
(i) paragraph 44(a) shall be replaced by the following:
‘(a) Väkeväglögiorspritglöggisaspiritdrinkproduced
by flavouring ethyl alcohol of agricultural originwith flavour of cloves and/or cinnamon using oneof the following processes: maceration and/or dis-tillation,redistillationofthealcoholinthepresenceof parts of the plants specified above, addition ofnatural flavouring substances as defined inArticle3(2)(c)ofRegulation(EC)No1334/2008ofcloves or cinnamon or a combination of thesemethods.’;
(j) paragraph 44(c) shall be replaced by the following:
‘(c) Otherflavourings,flavouringsubstancesand/orfla-
vouring preparations as defined in Article 3(2)(b),
(d) and (h) of Regulation (EC) No 1334/2008 mayalso be used, but the flavour of the specified spicesmust be predominant.’;
(k) Inpoint(c)ofparagraphs25,26,27,28,29,33,34,35,
36, 37, 38, 39, 40, 42, 43, 45 and 46, the word ‘prepa-rations’ shall be replaced by ‘flavouring preparations’.
Article 29
Amendment to Directive 2000/13/EC
In Directive 2000/13/EC, Annex III shall be replaced by the fol-
lowing:‘ANNEX III
DESIGNATION OF FLAVOURINGS IN THE LIST OF
INGREDIENTS
1. Without prejudice to paragraph 2, flavourings shall be des-
ignated by the terms
— “flavourings” or a more specific name or description of
theflavouring,iftheflavouringcomponentcontainsfla-vourings as defined in Article 3(2)(b), (c), (d), (e), (f), (g)and (h) of Regulation (EC) No 1334/2008 of the Euro-pean Parliament and of the Council of 16 December2008 on flavourings and certain food ingredients withflavouring properties for use in and on foods (
*);
— “smokeflavouring(s)”,or“smokeflavouring(s)produced
from“food(s)orfoodcategoryorsource(s)””(e.g.smokeflavouringproducedfrombeech),iftheflavouringcom-ponent contains flavourings as defined in Article 3(2)(f)ofRegulation(EC)No1334/2008andimpartsasmokyflavour to the food.
2. The term “natural” for the description of flavourings shall be
used in accordance with Article 16 of Regulation (EC)No 1334/2008.
(*) OJ L 354, 31.12.2008, p. 34.’
Article 30
Entry into force
This Regulation shall enter into force on the 20th day following
its publication in the Official Journal of the European Union .
It shall apply from 20 January 2011.Article 10 shall apply from 18 months after the date of applica-
tion of the Community list.
Articles26and28shallapplyfromthedateofapplicationofthe
Community list.
Article 22 shall apply from 20 January 2009. Foods lawfully
placedonthemarketorlabelledpriorto20January2011whichdo not comply with this Regulation may be marketed until theirdate of minimum durability or use-by-date.
This Regulation shall be binding in its entirety and directly applicable i n all Member States.
Done at Strasbourg, 16 December 2008.
For the European Parliament
The President
H.-G. PÖTTERINGFor the Council
The President
B. LE MAIRE31.12.2008 EN Official Journal of the European Union L 354/45ANNEX I
Community list of flavourings and source materials approved for use in and on foods
ANNEX II
List of traditional food preparation processes
Chopping Coating
Heating, cooking, baking, frying (up to 240 °C at
atmospheric pressure) and pressure cooking (up to 120 °C)Cooling
Cutting Distillation/rectification
Drying EmulsificationEvaporation Extra ction, incl. solvent extraction in accordance with
Directive 88/344/EEC
Fermentation FiltrationGrindingInfusion MacerationMicrobiological processes MixingPeeling PercolationPressing Refrigeration/FreezingRoasting/Grilling SqueezingSteepingL 354/46 EN Official Journal of the European Union 31.12.2008ANNEX III
Presence of certain substances
Part A:Substances which shall not be added as such to food
Agaric acid
AloinCapsaicin1,2-Benzopyrone, coumarinHypericineBeta-asarone1-Allyl-4-methoxybenzene, estragoleHydrocyanic acidMenthofuran4-Allyl-1,2-dimethoxybenzene, methyleugenolPulegoneQuassin1-Allyl-3,4-methylene dioxy benzene, safroleTeucrin AThujone (alpha and beta)
PartB:Maximumlevelsofcertainsubstances,naturallypresentinflavouringsa ndfoodingredientswithflavouringproperties,incer-
tain compound food as consumed to which flavourings and/or food ingredien ts with flavouring properties have been added
Name of the substance Compound food in which the presence of the substance i s restricted Maximum level mg/kg
Beta-asarone Alcoholic beverages 1,0
1-Allyl-4-methoxybenzene,
Estragol (*)Dairy products 50
Processed fruits, vegetables (incl. mushrooms, fungi, roots,
tubers, pulses and legumes), nuts and seeds 50
Fish products 50Non-alcoholic beverages 10
Hydrocyanic acid Nougat, marzipan or its substitutes or similar products 50
Canned stone fruits 5Alcoholic beverages 35
Menthofuran Mint/peppermint containing confectionery, except micro
breath freshening confectionery 500
Micro breath freshening confectionery 3 000Chewing gum 1 000Mint/peppermint containing alcoholic beverages 200
4-Allyl-1,2-dimethoxy-benzene,
Methyleugenol (
*)Dairy products 20
Meat preparations and meat products, including poultry and
game 15
Fish preparations and fish products 10Soups and sauces 60Ready-to-eat savouries 20Non-alcoholic beverages 131.12.2008 EN Official Journal of the European Union L 354/47Name of the substance Compound food in which the presence of the substance i s restricted Maximum level mg/kg
Pulegone Mint/peppermint containing confectionery, except micro
breath freshening confectionery 250
Micro breath freshening confectionery 2 000Chewing gum 350Mint/peppermint containing non-alcoholic beverages 20Mint/peppermint containing alcoholic beverages 100
Quassin Non-alcoholic beverages 0,5
Bakery wares 1Alcoholic beverages 1,5
1-Allyl-3,4-methylene dioxy
benzene, safrole (
*)Meat preparations and meat products, including poultry and
game 15
Fish preparations and fish products 15Soups and sauces 25Non-alcoholic beverages 1
Teucrin A Bitter-tasting spirit drinks or bitter (
1)5
Liqueurs (2) with a bitter taste 5
Other alcoholic beverages 2
Thujone (alpha and beta) Alcoholic beverages, except those produced from Artemisia
species 10
Alcoholic beverages produced from Artemisia species 35Non-alcoholic beverages produced from Artemisia species 0,5
Coumarin Traditionaland/orseasonalbakerywarecontainingareference
to cinnamon in the labelling 50
Breakfast cereals including muesli 20Finebakeryware,withtheexceptionoftraditionaland/orsea-
sonal bakery ware containing a reference to cinnamon in thelabelling 15
Desserts 5
(*) The maximum levels shall not apply where a compound food contains no added flavourings and the only food ingredients with flavour-
ing properties which have been added are fresh, dried or frozen herbs and sp ices. After consultation with the Member States and the
Authority, based on data made available by the Member States and on the newe st scientific information, and taking into account the use
of herbs and spices and natural flavouring preparations, the Commission, if appropriate, proposes amendments to this derogation.
(1) As defined in Annex II, paragraph 30 of Regulation (EC) No 110/2008.
(2) As defined in Annex II, paragraph 32 of Regulation (EC) No 110/2008.L 354/48 EN Official Journal of the European Union 31.12.2008ANNEX IV
List of source materials to which restrictions apply for their use in the pr oduction of flavourings and food
ingredients with flavouring properties
Part A:Source materials which shall not be used for the production of flavourings and food ingredients with flavouring properties
Source material
Latin name Common name
Tetraploid form of Acorus calamus L. Tetraploid form of Calamus
Part B:Conditions of use for flavourings and food ingredients with flavouring pr operties produced from certain source materials
Source material
Conditions of use
Latin name Common name
Quassia amara L. and
Picrasma excelsa (Sw)Quassia Flavourings and food ingredients with flavouring properties
producedfromthesourcematerialmayonlybeusedfortheproduction of beverages and bakery wares
Laricifomes officinales
(Vill.: Fr) Kotl. et Pouz
orFomes officinalisWhite agaric mushroom Flavourings and food ingredients with flavouring p roperties
producedfromthesourcematerialmayonlybeusedfortheproduction of alcoholic beverages
Hypericum perforatum L. St John’s wort
Teucrium chamaedrys L. Wall germander31.12.2008 EN Official Journal of the European Union L 354/49ANNEX V
Conditions for the production of thermal process flavourings and maximum levels for certain substances
in thermal process flavourings
Part A: Conditions for the production
(a) The temperature of the products during processing shall not exceed 180 °C.
(b) The duration of the thermal processing shall not exceed 15 minutes at 18 0 °C with correspondingly longer times at
lower temperatures, i.e. a doubling of the heating time for each decrease o f temperature by 10 °C, up to a maximum
of 12 hours.
(c) The pH during processing should not exceed the value of 8,0.
Part B: Maximum levels for certain substances
Substance Maximum levels µg/kg
2-amino-3.4,8-trimethylimidazo [4,5-f] quinoxaline (4,8-DiMeIQx) 50
2-amino-1-methyl-6-phenylimidazol [4,5-b]pyridine (PhIP) 50L 354/50 EN Official Journal of the European Union 31.12.2008